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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, implantable
510(k) Number K120268
Device Name AMID STAPLER
Original Applicant
SAFESTICH MEDICAL, LLC
4400 biscayne blvd.
suite 670
miami,  FL  33137
Original Contact alina caraballo
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received01/30/2012
Decision Date 02/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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